Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005380
Status:
COMPLETED
Last Update Posted:
2016-05-13
First Post:
2000-05-25
Brief Title:
Insulin Androgen and Risk in African-American Women
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2005-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To distinguish whether the observed gender differences in plasma insulin and insulin resistance reflect biologic differences or whether the gender differences in insulinemia are determined by greater adiposity in women Also to determine if the hyperinsulinemia per se contributes to excess risk for cardiovascular disease in African American women Finally since higher androgenicity is linked with cardiovascular risk in women to determine if the risk factors associated with hyperinsulinemia are modulated by sex hormones
Detailed Description:
BACKGROUND
Hyperinsulinemia and insulin resistance are strongly linked with essential hypertension EH and non-insulin dependent diabetes mellitus NIDDM both of which afflict African American women with greater incidence morbidity and mortality compared to Caucasians The insulin resistance syndrome is often characterized by upper body obesity In women this body morphology is related to higher levels of androgens In young adult African Americans the investigators have detected significant gender differences in both hyperinsulinemia and insulin resistance with African American women exhibiting higher plasma insulin and greater insulin resistance compared to men
Results of these studies should help to determine if insulin and androgens define risk for cardiovascular disease in African American women These data can lead to new insights to the excess prevalence of EH and NIDDM in African American women and to the development of strategies for prevention
The study was part of an NHLBI initiative on Collaborative Projects R01s on Minority Health The 1993 Report of the Committee on Appropriations House of Representatives encouraged the NHLBI to establish minority centers to facilitate the diagnosis and treatment of cardiovascular disease The concept for the initiative was developed by Institute staff and approved by the National Heart Lung and Blood Advisory Council in September 1992 The Institute-wide Request for Applications was released in October 1992
DESIGN NARRATIVE
The study was designed to test the overall hypothesis that cosegregation of hyperinsulinemia and androgenicity correlated with greater cardiovascular risk in African American women Women who have hyperinsulinemia and higher androgen levels have high blood pressure impaired glucose tolerance and altered serum lipids as compared to women who do not have both phenotypes The study was conducted on a population of young adult African American men and women that had been studied longitudinally Mothers of the young women were also studied The investigators obtained anthropometric and blood pressure measures quantitated glucose tolerance by glucose tolerance test and insulin sensitivity by insulin clamp measured serum lipids and assessed androgen levels using assays of plasma sex-hormone binding globulin and free testosterone
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
As part of a collaborative project on minority health Dr Falkner is collaborating with Dr Thomas Tulenko R01HL51538 and Dr Julian Marsh R01HL51536
Hyperinsulinemia and insulin resistance are strongly linked with essential hypertension EH and non-insulin dependent diabetes mellitus NIDDM both of which afflict African American women with greater incidence morbidity and mortality compared to Caucasians The insulin resistance syndrome is often characterized by upper body obesity In women this body morphology is related to higher levels of androgens In young adult African Americans the investigators have detected significant gender differences in both hyperinsulinemia and insulin resistance with African American women exhibiting higher plasma insulin and greater insulin resistance compared to men
Results of these studies should help to determine if insulin and androgens define risk for cardiovascular disease in African American women These data can lead to new insights to the excess prevalence of EH and NIDDM in African American women and to the development of strategies for prevention
The study was part of an NHLBI initiative on Collaborative Projects R01s on Minority Health The 1993 Report of the Committee on Appropriations House of Representatives encouraged the NHLBI to establish minority centers to facilitate the diagnosis and treatment of cardiovascular disease The concept for the initiative was developed by Institute staff and approved by the National Heart Lung and Blood Advisory Council in September 1992 The Institute-wide Request for Applications was released in October 1992
DESIGN NARRATIVE
The study was designed to test the overall hypothesis that cosegregation of hyperinsulinemia and androgenicity correlated with greater cardiovascular risk in African American women Women who have hyperinsulinemia and higher androgen levels have high blood pressure impaired glucose tolerance and altered serum lipids as compared to women who do not have both phenotypes The study was conducted on a population of young adult African American men and women that had been studied longitudinally Mothers of the young women were also studied The investigators obtained anthropometric and blood pressure measures quantitated glucose tolerance by glucose tolerance test and insulin sensitivity by insulin clamp measured serum lipids and assessed androgen levels using assays of plasma sex-hormone binding globulin and free testosterone
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
As part of a collaborative project on minority health Dr Falkner is collaborating with Dr Thomas Tulenko R01HL51538 and Dr Julian Marsh R01HL51536
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL051547 | NIH | None | httpsreporternihgovquickSearchR01HL051547 |